Nicholas Aralis

WORK HISTORY

EDUCATION

SKILLS

ABOUT NICHOLAS ARALIS

A technical professional who possesses skill in leadership & management and a proven ability in research & development, denoted during 9 years of experience by: an ACS chemistry degree, 13+ product lines launched, 131+ hours of continuing education, 20+ conferences attended, 7 publications, 3 articles, 11 FDA cleared 510(k)’s, and collaboration relationships.Skills: •Develops strategic vision, and constructs Product Development Roadmap.•Manages and optimizes a portfolio of projects within the Product Development Program.•Engages Key Opinion Leaders and internal stakeholders to assess needs and clearly define identified opportunities.•Creates, utilizes, and Continuously Improves (CI) a Product Development Process including:1) Use of Design Control and Phase Gate development approach.2) Use of MS Project, and PMP tools to clearly define goals and milestones. 3) Use of KPI’s to clearly evaluate progress, address challenges, adhere to budget and ensure timely completion.4) Creation of visual and substantive presentations including program & project updates.•Facilitates Product Management in creation of training and sales collateral.•Coordinates with key departments (RA, Engineering, Manufacturing, Sales, etc.) to ensure effective collaboration, and efficient utilization of resources.•Manages a diverse team ranging from manufacturing staff to PhD senior level technical staff.•Creates an inclusive workplace, facilitates others’ development, teamwork, and constructive resolution of conflicts.•Facilitates staff development, by individual mentoring, assisting with development plans, encouraging outreach, and identifying growth opportunities.•Encourages decision-making, which produces high-quality results via technical knowledge, analysis, and risk calculation.•Partners w/ RA to ensure comprehensive, ongoing compliance of the Quality Management System.•Specializes in FDA ISO BS EN,(cGMP cGLP, 21CFR820 - QSR, ISO 13485, Canadian MDR, MDD-93/42) regulations.